Comparing Diets for Weight Loss and Improvement in Cancer Biomarkers in Men With Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Miriam Hospital
- Enrollment
- 30
- Primary Endpoint
- weight loss
Study Overview
Brief Summary
This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.
Detailed Description
Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •prostate cancer, BMI 25.0 to 40.0 kg/m2
Exclusion Criteria
- Not provided
Arms & Interventions
Prostate Cancer Foundation diet
Intervention: 8-weeks of a Prostate Cancer Foundation diet
Intervention: Plant- based, olive oil diet (Other)
Prostate Cancer Foundation diet
Intervention: 8-weeks of a Prostate Cancer Foundation diet
Intervention: Prostate Cancer Foundation diet (Other)
plant- based, olive oil diet
Intervention: 8 weeks of a plant-based, olive oil diet
Intervention: Plant- based, olive oil diet (Other)
plant- based, olive oil diet
Intervention: 8 weeks of a plant-based, olive oil diet
Intervention: Prostate Cancer Foundation diet (Other)
Outcomes
Primary Outcomes
weight loss
Time Frame: 8 weeks
Secondary Outcomes
- improvement in in fasting blood glucose and insulin(8 weeks)
Investigators
Mary Flynn
Research dietitian, Associate professor of Medicine
The Miriam Hospital